buprenorphine

Manufacturer
PAYLESS COMPOUNDERS, LLC
Effective date
2024-12-11
Label type
ANIMAL COMPOUNDED DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:51:18

Label at a glance#

Productbuprenorphine
Active ingredientBUPRENORPHINE HYDROCHLORIDE
Label structure4 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Buprenorphine MDV 0.3mg/mL
Buprenorphine MDV 0.3mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

buprenorphine inj MDV 0.6mg/mL
buprenorphine inj MDV 0.6mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

buprenorphine oral solution 30mL
buprenorphine oral solution 30mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

buprenorphine oral solution 100mL
buprenorphine oral solution 100mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238129buprenorphine HCl 0.3 MG in 1 ML InjectionPSN10
2381291 ML buprenorphine 0.3 MG/ML InjectionSCD10
238129buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) InjectionSY10
238129buprenorphine HCl 0.3 MG per 1 ML InjectionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BUPRENORPHINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70022-001-10buprenorphine10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1010
70022-004-10buprenorphine10 mL in 1 VIAL, MULTI-DOSESOLUTION1010
70022-010-03buprenorphine30 mL in 1 BOTTLE, PLASTICSOLUTION3010
70022-010-10buprenorphine100 mL in 1 BOTTLE, PLASTICSOLUTION10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70022-001BUPRENORPHINE INJECTION, SOLUTION BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]101 package rows20241213_a1c1f498-e101-467f-b81c-1451c44e7a01.zip
70022-004BUPRENORPHINE INJECTION, SOLUTION BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]101 package rows20241213_a1c1f498-e101-467f-b81c-1451c44e7a01.zip
70022-010BUPRENORPHINE INJECTION, SOLUTION BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]102 package rows20241213_a1c1f498-e101-467f-b81c-1451c44e7a01.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
38779-0888-0GM - Gram38779-0888ea475beb-91f1-4bce-ba3e-3ec1b988f3f912014-09-03
38779-0888-1GM - Gram38779-08883fd81d18-9e25-45de-8c87-ee5e50fce5a812014-09-03
38779-0888-3GM - Gram38779-088842cd3e9d-3565-4121-972d-4b8020e2221612014-09-03
38779-0888-6GM - Gram38779-0888356a495c-16ae-4ea4-8c6c-20d53148d9b412014-09-03
38779-0888-9GM - Gram38779-08885b7015c7-96d3-4be2-bb53-082d7a26398612014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN11
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZ1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 291 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii candidate
61 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEAdvagen Pharma Ltd699638dd-3a53-445f-a545-d0e6eabfe1c92026-07-17Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
BuprenorphineBUPRENORPHINEREMEDYREPACK INC.aa86a438-1ebf-4c08-bf27-38f1e81efb3a2026-07-07Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEREMEDYREPACK INC.11686845-f5fd-4e96-8a4f-9b132bf488402026-07-07Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5578cd5c-c860-6e8a-e063-6394a90a56c72026-06-30Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackaa132031-9d12-45b4-81e0-4a58776613792026-06-29Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINEBryant Ranch Prepack655e3e52-03be-496c-978a-5cffc74b2ae42026-06-29Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5479b218-a388-2c3c-e063-6294a90a0e852026-06-17Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepack966adb01-71b4-4e0b-bbc6-b83da9987aa22026-06-16Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINEMajor Pharmaceuticalsdba586f9-e3f2-4b9c-849b-907c81a5a0ef2026-06-16Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackbc5a7137-9e8f-438e-84d9-bdbf1db129982026-06-03Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINERhodes Pharmaceuticals LLC2738feae-316e-426f-971c-5f142ac01b602026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BuprenorphineBUPRENORPHINEActavis Pharma, Inc.03819118-86f6-4329-adaf-4599e7b71f462026-05-25Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BuprenorphineBUPRENORPHINETeva Pharmaceuticals USA, Inc.36995ce3-b515-447b-baa9-aa14f84060d82026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals LLCda90618a-5621-4b15-bc48-9dcc631418de2026-05-04Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINEINGENUS PHARMACEUTICALS, LLC186e3be6-8bc0-4bb9-96f5-429d53632f452026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BuprenorphineBUPRENORPHINEAveva Drug Delivery Systems Inc.1aae9b13-7431-42ef-8558-14a2325820e62026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
BuprenorphineBUPRENORPHINESun Pharmaceutical Industries, Inc.9fd1f18f-0b0f-4059-b603-19ecbf0ed63a2026-02-11Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEA-S Medication Solutionsbfb02ea5-22f2-432e-afc8-f1dbe2ea06142026-02-06Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.